Zoo Pack Elastic

Basic Information

• Brand Name: Zoo Pack Elastic
• Primary DI: 00889989055337
• Version / Model: 634-0002
• Company Name: ORMCO CORPORATION
• Labeler DUNS: 154614119
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2023-08-14
• Public Version: 1
• Public Version Date: 2023-08-22
• Public Version Status: New
• Public Device Record Key: a054ac6d-a679-44c6-a9bc-841b2c4cf1c6

Device Description

ZOO MASTER POUCH 4G 5/16 8OZ PANTHER

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ECI	BAND, ELASTIC, ORTHODONTIC	Dental	872.5410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62074	Orthodontic inter-arch elastic band	A non-sterile circular band intended to be used during orthodontic treatment to exert a continuous light force to adjust bite and jaw position for correcting malocclusions (e.g., overbite, underbite). It is made of an elastomeric material (e.g., polyurethane, rubber) and is secured to hooks on orthodontic brackets across non-opposing mandibular and maxillary teeth. This is a single-patient device intended to be replaced regularly during orthodontic treatment (single-use).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	30889989055338	GS1
Primary	00889989055337	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			5/16inches, 7.94mm